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FDA: an approved suitability petition allows pursuing a petition ANDA but does not guarantee later ANDA approval
Summary
FDA staff warned that approval of a suitability petition permits an applicant to file a petition ANDA, but the ANDA must still meet bioequivalence and other requirements and will not necessarily be therapeutically equivalent in FDA listings.
Commander Andrew Fine closed the technical portion of the presentation with reminders about what an approved suitability petition does and does not accomplish for a sponsor.
"An approved petition does not guarantee future AND approval," Fine said, adding that petition ANDAs still require appropriate bioequivalence testing or additional information to demonstrate the same therapeutic effect as the RLD. He also noted that petition ANDAs may not be listed as therapeutically equivalent to the RLD in the Orange Book in the same way as a pharmaceutically equivalent product.
Fine urged applicants to prepare ANDA submissions with appropriate BE testing and product-specific administration instructions where applicable, and to understand that labeling assessments at the petition stage are less thorough than a later ANDA review.
